Transcranial Magnetic Stimulation as Treatment for Persistent PTSD in Texas Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Side Effects of TMS treatment
研究概览
简要总结
The purpose of this study is to test whether transcranial magnetic stimulation, or TMS, is an acceptable and helpful treatment for ongoing symptoms of posttraumatic stress syndrome disorder (PTSD) in 12-20 year olds. Ongoing PTSD refers to symptoms that continue after completing trauma-focused psychotherapy. About 1 in 4 patients need additional help to overcome PTSD after completing psychotherapy. Currently, scientists do not know the best way to help adolescents with persistent PTSD, and this study will test TMS as a possible treatment, and hopefully lead to future studies including more people.
详细描述
Trauma is a common occurrence among youth. Almost 60% of American youths experience a traumatic event before age 18, such as physical or sexual abuse, sudden loss of caregivers, or witnessing violence in the community or the home. Distress after a significantly traumatic event is to be expected, but for some youths, symptoms of posttraumatic stress disorder (PTSD) linger for months or years, and can become chronic if left untreated. Symptoms of PTSD can include upsetting memories, avoidance of reminders, and emotional numbing, and other symptoms. These symptoms can create difficulties for family relationships, friendships, and schoolwork. Currently, the most effective treatment for PTSD is talk therapy (trauma-focused psychotherapy). However, sometimes young people continue to have symptoms of PTSD after completing talk therapy, and it is currently not known the best way to help with these persistent symptoms.
In this study, the total length of time participants will be involved in the study is about 16-weeks. During that time, participants will be asked to attend approximately 6 research visits and 10 treatment visits, for a total of 16 visits. The 6 research visits include a screening visit, an interview visit, 2 MRI visits, and 2 follow-up visits. The screening, interview, and follow-up visits can be completed virtually, over zoom. The study will include 2 MRI visits and 10 treatment visits. Virtual follow-up visits will be conducted 1 and 3 months after completion of treatment and will include interviews and questionnaires about participants symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females; Age 12-20
- •Have previously completed at least 9 sessions of trauma-focused therapy in our clinical trial or in the community
- •Have current self-reported symptom score of 20 or greater on the UCLA PTSD Reaction index
- •Willing to attend 10 TMS treatment sessions within a 30-day period
- •Fluent in English
排除标准
- •History of seizures
- •History of head injury with loss of consciousness and concussive sequelae
- •Brain abnormality such as tumor or other observable abnormality
- •Currently receiving psychotherapy or TMS treatment
- •Currently pregnant
- •MRI contraindications (metal in body, orthodontic braces)
- •Diagnosis of bipolar 1 or a psychotic disorder
研究组 & 干预措施
TMS treatment group
Each treatment visit will take about 1.5 hours. Participants will receive up to 4 TMS treatment sessions during the visit, with each session lasting about 10-minutes. After the TMS sessions, there will be a brief visit with a psychotherapist.
干预措施: MagPro R30 with robotic arm (Device)
结局指标
主要结局
Side Effects of TMS treatment
时间窗: Day 1 of treatment through Day 30
number of side effects reported per participant
Number of Adverse Events
时间窗: Day 1 of treatment through Day 30
Number of adverse events experienced by study participants through the treatment phase of the study
Completion rate of Treatment
时间窗: Day 1 of treatment through Day 30
Number of participants that completed the TMS treatment
次要结局
- Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)(CAPS-5)(Baseline to 90 days)
- Assessment of Depression using Patient Health Questionnaire-9 (PHQ-9)(Baseline to Day 30)
研究者
Amy Garrett, PhD
Associate Professor
The University of Texas Health Science Center at San Antonio
